AML patients with a history of antecedent MDS or MPD are eligible for treatment in this study.

In the opinion of the investigator is ineligible for or has declined treatment with standard induction therapy

ECOG performance status of equal to or less then 3

Ability to voluntarily provide written informed consent

Determination of the presence or absence of a FLT3-ITD mutation before enrollment once it is ascertained that determination of FLT3-ITD mutation status is required to avoid exceeding enrollment in either patient group

Exclusion Criteria:

Presence of an active malignancy other than AML at the time of study entry

Documented or suspected central nervous system leukemia involvement

Known gastrointestinal disease that could interfere with the absorption of oral tandutinib

Receipt of prior antineoplastic therapy for leukemia, except that prior therapy with the following is allowed:

Leukapheresis

Treatment for hyperleukocytosis with hydroxyurea

Receipt of prior antineoplastic therapy for MDS, except that prior therapy with the following is allowed:

Growth factor/cytokine support

Lenalidomide (Revlimid™)

Thalidomide (Thalomid®)

Azacitidine (Vidaza®)

Decitabine (Dacogen)

Receipt of prior antineoplastic therapy for MPD, except that prior therapy with the following is allowed:

Interferon alpha

Anagrelide (Agrylin®)

Hydroxyurea

Antineoplastic, experimental, or radiation therapy within 3 weeks before Day 1, except that hydroxyurea for the treatment of hyperleukocytosis is permitted

Major surgery within 2 weeks before Day 1

Men or women of childbearing potential unwilling to use adequate contraception from screening to 30 days after the last dose of tandutinib

A woman who is pregnant or breast feeding. Confirmation that the patient is not pregnant must be established by a negative serum or urine B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during the screening period. Pregnancy testing is not required for postmenopausal or surgically sterilized women.

Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.